Belimumab for Interstitial Lung Disease

(BEconneCTD-ILD Trial)

Recruiting at 108 trial locations

Overseen By US GSK Clinical Trials Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: GlaxoSmithKline

Must be taking: Standard therapy

Disqualifiers: Systemic sclerosis, Rapidly progressive disease, Emphysema, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

440 Participants Needed

Trial Summary

What is the purpose of this trial?

Interstitial lung disease (ILD) is a lung condition resulting in inflammation and stiffening of the lung, often associated with connective tissue diseases (CTDs). ILD causes reduction in lung volume, shortness of breath, cough and fatigue therefore has high impact on quality of life and is also the leading cause of death in participants with these conditions. The study will assess whether treatment of CTD-ILD participants with belimumab in addition to standard therapy will result in the stabilization and/or improvement of lung function and improve symptoms associated with ILD with an acceptable safety profile.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it mentions that participants must be on stable standard therapy for ILD or underlying CTD. It seems likely that you can continue your current treatment.

How is the drug Belimumab different from other treatments for interstitial lung disease?

Belimumab is unique because it is a monoclonal antibody that targets and inhibits a specific protein involved in the immune system, which may help reduce inflammation in interstitial lung disease. This approach is different from other treatments like nintedanib, which primarily focuses on slowing disease progression rather than modulating the immune response. ^{1 2 3 4 5}

Research Team

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Eligibility Criteria

This trial is for adults with a lung condition called Interstitial Lung Disease (ILD) that's linked to Connective Tissue Disease (CTD). Participants should have symptoms like reduced lung volume, breathlessness, coughing, and fatigue. The study seeks individuals who can take additional standard therapy alongside the trial treatment.

Inclusion Criteria

I am on a stable treatment for my lung disease or connective tissue disease, or I couldn't tolerate the first treatment.

I can take my medication by myself or have someone who can help me.

I can sign and understand the consent form.

Exclusion Criteria

I have a lung condition that makes it hard to breathe.

My lung scans show more damage from emphysema than from ILD.

I have never had bleeding in my lungs or similar lung problems.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive belimumab or placebo in addition to standard therapy to assess stabilization and/or improvement of lung function

52 weeks

Regular visits throughout the treatment period

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Belimumab

Trial Overview The study is testing Belimumab versus a placebo to see if it helps stabilize or improve lung function and symptoms in patients with ILD associated with CTD. It aims to determine if adding Belimumab to regular treatments offers better outcomes.

Participant Groups

Group I: Belimumab Experimental Treatment 1 Intervention

Participants will receive belimumab in addition to standard therapy.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive placebo in addition to standard therapy.

Belimumab is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Benlysta for:

• Systemic lupus erythematosus (SLE)

Approved in European Union as Benlysta for:

• Systemic lupus erythematosus (SLE)

Approved in Canada as Benlysta for:

• Systemic lupus erythematosus (SLE)

Approved in Japan as Benlysta for:

• Systemic lupus erythematosus (SLE)

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Findings from Research

In the INBUILD trial involving 663 patients with chronic fibrosing interstitial lung diseases, nintedanib significantly reduced the rate of lung function decline (measured by forced vital capacity) compared to placebo, regardless of glucocorticoid use.

The safety profile of nintedanib remained consistent whether patients were using immunomodulatory therapies or not, suggesting it can be safely combined with these treatments in managing progressive fibrosing ILDs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nintedanib and immunomodulatory therapies in progressive fibrosing interstitial lung diseases. Cottin, V., Richeldi, L., Rosas, I., et al.[2021]

In a study of 216 patients with non-small cell lung cancer (NSCLC), those with interstitial lung disease (ILD) experienced significantly higher rates of nivolumab-related pneumonitis (31% vs. 12%) compared to those without ILD, indicating a greater risk of lung toxicity in this group.

Despite the increased incidence of pneumonitis, most cases were manageable, and no deaths occurred due to nivolumab-related pneumonitis, suggesting that nivolumab can still be a viable treatment option for NSCLC patients with ILD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of nivolumab in non-small cell lung cancer with preexisting interstitial lung disease. Kanai, O., Kim, YH., Demura, Y., et al.[2022]

In the INBUILD trial involving 170 patients with fibrosing autoimmune disease-related interstitial lung diseases, nintedanib significantly slowed the decline in lung function (measured by forced vital capacity) compared to placebo, with a difference of 102.7 ml/year over 52 weeks.

While nintedanib was effective, it was associated with a higher incidence of adverse events, particularly diarrhea, affecting 63.4% of patients, though most side effects were manageable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nintedanib in Patients With Autoimmune Disease-Related Progressive Fibrosing Interstitial Lung Diseases: Subgroup Analysis of the INBUILD Trial. Matteson, EL., Kelly, C., Distler, JHW., et al.[2022]

In a study of 194 interstitial lung disease (ILD) patients over 12 months, about 30% experienced a significant decline in health-related quality of life (HRQL), as measured by the K-BILD questionnaire and EQ-5D Visual Analog Scale.

Lower baseline lung function, specifically forced vital capacity (FVC) and diffusing capacity of carbon monoxide (DLCO), was linked to HRQL deterioration, highlighting the importance of maintaining lung function to support patient well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determinants of health-related quality of life decline in interstitial lung disease. Maqhuzu, PN., Szentes, BL., Kreuter, M., et al.[2020]

In a study of 50 patients with severe, progressive interstitial lung disease (ILD) treated with rituximab, there was a significant median improvement in forced vital capacity (FVC) of 6.7% after treatment, indicating potential efficacy as a rescue therapy.

Despite the benefits, there were safety concerns, as two patients experienced serious infections and ten patients died from disease progression within a median of 5.1 months post-treatment, highlighting the need for further research on safety outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rituximab in severe, treatment-refractory interstitial lung disease. Keir, GJ., Maher, TM., Ming, D., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Nintedanib and immunomodulatory therapies in progressive fibrosing interstitial lung diseases. [2021]

2. Singapore pubmed.ncbi.nlm.nih.gov

Efficacy and safety of nivolumab in non-small cell lung cancer with preexisting interstitial lung disease. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Nintedanib in Patients With Autoimmune Disease-Related Progressive Fibrosing Interstitial Lung Diseases: Subgroup Analysis of the INBUILD Trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Determinants of health-related quality of life decline in interstitial lung disease. [2020]

5. Australia pubmed.ncbi.nlm.nih.gov

Rituximab in severe, treatment-refractory interstitial lung disease. [2022]